Method and apparatus for treating dysphagia with electrical stimulation

ABSTRACT

This invention is directed to a simple, non-invasive method and device for treating dysphagia and artificially promoting swallowing by electrical stimulus. In the present invention, a plurality of electrodes are selectively placed in electrical contact with tissue of a pharyngeal region of patient and a series of electrical pulses in electrical contact with each of the plurality of electrodes with a generator. The generator includes a pulse rate modulator for generating each of the electrical pulses having a frequency generally fixed at 80 hertz, a pulse width modulator for generating each pulse of the series of electrical pulses at a duration generally fixed at 300 microseconds, and a governor for regulating the electrical pulses such that at least one of current so as not to exceed 4.4 milliamps RMS or power so as not to exceed 9.6 MW RMS. The electrical pulses selectively stimulate muscles located proximate to the selectively placed electrodes to initiate swallowing.

BACKGROUND OF THE INVENTION

This invention relates to a method and device for effectively treatingdysphagia. In particular, the present invention relates to a method anddevice for treating dysphagia by providing electrical stimulation to thepharyngeal region of an associated animal.

Dysphagia is the inability to swallow or difficulty in swallowing andmay be caused by stroke, neurodegenerative diseases, or respiratorydisorders. Swallowing is a complicated action which is usually initiatedvoluntarily but always completed reflexively, whereby food is moved fromthe mouth through the pharynx and esophagus to the stomach. The act ofswallowing occurs in three stages and requires the integrated action ofthe respiratory center and motor functions of multiple cranial nerves,and the coordination of the autonomic system within the esophagus.

In the first stage, food is placed on the surface of the tongue. The tipof the tongue is placed against the hard palate. Elevation of the larynxand backward movement of the tongue forces the food through the isthmusof the fauces in the pharynx. In the second stage, the food passesthrough the pharynx. This involves constriction of the walls of thepharynx, backward bending of the epiglottis, and an upward and forwardmovement of the larynx and trachea. Food is kept from entering the nasalcavity by elevation of the soft palate and from entering the larynx byclosure of the glottis and backward inclination of the epiglottis.During this stage, respiratory movements are inhibited by reflex. In thethird stage, food moves down the esophagus and into the stomach. Thismovement is accomplished by momentum from the second stage, peristalticcontractions, and gravity. Although the main function of swallowing isthe propulsion of food from the mouth into the stomach, swallowing alsoserves as a protective reflex for the upper respiratory tract byremoving particles trapped in the nasopharynx and oropharynx, returningmaterials refluxed from the stomach into the pharynx, or removingparticles propelled from the upper respiratory tract into the pharynx.Therefore, the absence of adequate swallowing reflex greatly increasesthe chance of pulmonary aspiration.

In the past, patients suffering from dysphagia have undergone dietarychanges or thermal stimulation treatment to regain adequate swallowingreflexes. Thermal stimulation involves immersing a mirror or probe inice or cold substance. The tonsillar fossa is stimulated with the mirroror probe and the patient closes his mouth and attempts to swallow. Whilethese traditional methods are usually effective for treating dysphagia,these methods often require that the patient endure weeks or months oftherapy.

Electrical stimulation has often been used as a method for alleviatingpain, stimulating nerves, and as a means for diagnosing disorders of thespinal cord or peripheral nervous system. Electrical stimulation hasfurther been used to facilitate muscle reeducation and with otherphysical therapy treatments. In the past, electrical stimulation was notrecommended for use in the neck or thoracic region as severe spasms ofthe laryngeal and pharyngeal muscles may occur resulting in closure ofthe airway or difficulty in breathing. Further, the introduction ofelectrical current into the heart may cause cardiac arrhythmia.Electrical stimulation has been used to stimulate the recurrentlaryngeal nerve to stimulate the laryngeal muscles to control theopening of the vocal cords to overcome vocal cord paralysis, to assistwith the assessment of vocal cord function, to aid with intubation, andother related uses. However, heretofore, electrical stimulation has notbeen used in the treatment of dysphagia to promote the swallowing reflexwhich involves the integrated action of the respiratory center and motorfunctions of multiple cranial nerves, and the coordination of theautonomic system within the esophagus.

It is desirable to have a simple, non-invasive method and device fortreating dysphagia and artificially promoting swallowing.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided a simple,non-invasive method and device for treating dysphagia and artificiallypromoting swallowing, wherein electrical stimulus is provided to thepharyngeal region of a patient to stimulate muscles located in thepharyngeal region in order to promote swallowing.

In accordance with the present invention, there is provided a simple,non-invasive method for treating dysphagia and artificially promotingswallowing by electrical stimulus, the method comprising selectivelyplacing electrodes in electrical contact with tissue of a pharyngealregion of patient and generating a series of electrical pulses inelectrical contact with each of the plurality of electrodes, wherein theelectrodes deliver a series of electrical pulses to selectivelystimulate muscles located proximate to the selectively placed electrodesto initiate swallowing.

In accordance with the present invention, there is provided a simple,non-invasive device for treating dysphagia and artificially promotingswallowing, the device comprising a plurality of electrodes adapted tobe selectively placed in electrical contact with tissue of a pharyngealregion of a patient and a generator for generating a series ofelectrical pulses in electrical contact with each of the plurality ofelectrodes, the generator comprising a pulse rate modulator forgenerating each of the electrical pulses having a frequency generallyfixed at 80 hertz, a pulse width modulator for generating each pulse ofthe series of electrical pulses at a duration generally fixed at 300microseconds, and a governor for regulating the electrical pulses suchthat at least one of the current so as not to exceed 4.4 milliamps RMSor power so as not to exceed 9.6 MW RMS.

These and other aspects of the invention will be apparent to thoseskilled in the art upon reading and understanding the specification thatfollows.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may take physical form in certain parts and arrangementsof parts, a preferred embodiment and method of which will be describedin detail in this specification and illustrated in the accompanyingdrawings which form a part hereof, and wherein:

FIG. 1 is a simplified fragmentary illustration of an electricalpharyngeal neuromuscular stimulator for use in promoting swallowingaccording to the present invention;

FIG. 2 is a flow chart of a method for electrical pharyngealneuromuscular stimulation for promoting swallowing according to thepresent invention;

FIG. 3 is a view of a portion a pharyngeal region of a patientillustrating placement of electrodes according to the present invention;

FIG. 4 is a view of a portion a pharyngeal region of a patientillustrating placement of electrodes according to the present invention;and

FIG. 5 is a graph illustrating the effectiveness of electric pharyngealneuromuscular stimulation method and device according to the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

This invention is directed to a simple, non-invasive method and devicefor electrical pharyngeal neuromuscular stimulation for artificiallypromoting swallowing wherein electrical stimulus is provided to thepharyngeal region of a patient to stimulate muscles located in thepharyngeal region in order to promote swallowing. Referring now to thedrawings wherein the showings are for the purposes of illustrating thepreferred embodiment of the invention only and not for purposes oflimiting same, the electrical pharyngeal neuromuscular stimulationdevice 10 as shown in FIG. 1 is comprised of a plurality of electrodes12 adapted to be selectively placed in electrical contact with tissue ofa pharyngeal region of a patient and a generator 20 for generating aseries of electrical pulses in electrical contact with each of theplurality of electrodes.

The device 10 is preferably comprised of two electrodes. The electrodes22 are preferably made of metal or some other physiologically acceptableconductive material. In general, the electrodes 12 are suitably anyconventional and convenient shape which is suited for physiologicalapplications. Lead wires 14 are attached to each electrode and aresuitable for attachment to the generator 20. The lead wires 14 are madefrom any physiologically acceptable conductive metal, preferablyinsulated aluminum wire.

The subject wave forms are suitably realized by selective control of apulse generator 20 working in connection with an amplifier 18. Thegenerator 20 is comprised of a pulse rate modulator or a frequencycontroller 22 for generating each of the electrical pulses having afrequency generally fixed at 80 hertz. The generator 20 is alsocomprised of a pulse width modulator suitably accomplished by anon/off/duration control 24 for generating each pulse of the series ofelectrical pulses at a duration generally fixed at 300 microseconds. Thegenerator is further comprised of a governor 26 for regulating theelectrical pulses such that the electrical current does not exceed 4.4milliamps RMS, the power does not exceed 9.6 MW RMS, or both. Thecurrent applied will vary depending on the physical condition andtolerance of the patient but the current applied should be sufficient toproduce the desired response and promote the swallowing reflex. Theintensity of the current is increased by small increments until thetolerance and comfort level limits are reached in the patient. However,the current which is applied must not be too intense and therefore,result in laryngeal spasms or cardiac arrhythmia in the patient. Anotherinput to pulse generator 20 is formed from amplitude control module 28.The amplitude control module 28 allows for selective control of anamplitude of pulses generated from pulse generator 20. The channelselector 30 suitably forms another input to amplifier 18 to allow forconcurrent activation of sets of electrodes 12. The status of channelselector 30 is advantageously indicated by channel selector indicator32.

In one embodiment of the present invention, the generator continuouslygenerates electrical pulses for a predetermined period of time.Preferably, electric pulses are continuously generated and delivered tothe electrodes until a complete swallow is achieved or the tolerancelevel is reached in the patient. Additional treatments wherein thegenerator continuously generates electric pulses are suitably performedon the patient as necessary.

In another embodiment of the present invention, the generatorselectively generates cycles of electrical pulses. The generator isfurther comprised of a treatment time controller which is also suitablyaccomplished with the control 26 real time information which is providedby a timer 40. The timer 40, control 26, and pulse generator 16 alsoserve to provide functions of a treatment off-time controller, anon-ramp controller, and an off-ramp controller Treatment time controlselectively controls the duration of time wherein the generatorselectively generates cycles of electric pulses. The treatment time isany suitable period, such as fifteen, thirty, or sixty minutes. As withall settings, the particular values are highly application and patientspecific. Thus, a suitable duration of the electric pulses in each cycleis set. Preferably, the duration of electric pulses in each cycle is therange of about 0.5 seconds to about 30 seconds. A selection is made foran amount of time between each cycle. Preferably, the amount of timebetween cycles is from about 0.1 seconds to about 60 seconds. Aselection is also made for the amount of time required to reach themaximum intensity in each cycle. Preferably, the amount of time requiredto reach the maximum intensity is between about 0.1 seconds to about 6.0seconds. A selection is further made for the amount of time required todecrease from the maximum intensity to zero intensity at the end of eachcycle. Preferably, the amount of time required to decrease from themaximum intensity to zero intensity is between about 0.1 seconds toabout 6.0 seconds. A suitable commercially available device whichprovides the functions described above is found in the Staodyn® EMS+2System manufactured by Staodyn, Inc. and described in the associatedinstruction manual which is herein incorporated by reference.

FIG. 2 provides a flow chart of the method for electrical pharyngealneuromuscular stimulation for promoting swallowing according to thepresent invention. Turning to block 100, the procedure for treatingdysphagia with electrical stimulation is commenced. Next, at block 102,actual electrodes are applied to the pharyngeal area of a patient. Theparticulars for electrode placement and selection have been disclosedelsewhere in the subject application.

Turning next to block 104, a pulse frequency is set in accordance withthe parameters disclosed above. Similarly, at block 102, pulse durationis set. Finally, at block 108, a determination of a treatment durationis made, as well as to the number of treatment periods which are to beapplied.

Turning next to block 110, an actual waveform associated with thepreviously selected parameters is applied to the pharyngeal area of apatient. Next, at block 112, a determination is made as to whether atreatment period has been completed in accordance with the preselectedstandards. A positive determination causes profess to decision block 114and a negative determination causes progress to block 116. At block 116,a set duration is applied as a wait period for which progress isreturned to block 110, as described above.

At block 114, a determination is made as to whether there are furthertreatment periods merited. A positive determination causes a return toblock 110. Negative determination signals completion of the treatmentprocedure and progress to termination block 118.

The electrodes are selectively placed in any suitable site within thepharyngeal region 200 of the patient as shown in FIGS. 3 and 4. Theplacement of the electrodes in the pharyngeal region of the patient isbased on several factors, such as the extent and type of dysphagiaexhibited by the patient and, given the extent and type of dysphagiaexhibited, those locations within the pharyngeal region, when subjectedto electrical stimulus, have the possibility of eliciting the strongestand most complete swallow. An evaluation for swallowing ability is doneon the patient to determine the extent and type of dysphagia. Thecritical elements in the evaluation are to determine the presence of agag reflex, a dry swallow, and ability to tolerate one's own secretions.The placement of the electrodes may be changed several times in aneffort to obtain the strongest and most effective treatment.

As shown in FIGS. 3 and 4, in one embodiment of the invention, a pair ofelectrodes 202 is positioned on the skin of the pharyngeal region 200 atapproximately the position of the lesser horn 204 of the hyoid bone 206on either side of the pharyngeal region 200 and just above the body ofthe hyoid bone 206. The electrodes overlie the muscles of the floor ofthe mouth (not shown).

In a second embodiment of the present invention, a pair of electrodes208 is positioned on the skin of the pharyngeal region 200 on one sideof the midline of the pharyngeal region 200. One electrode 208a isplaced on the thyrohyoid membrane 210 at approximately the level of thelesser horn 204 close to the hyoid bone 206. This electrode 208aoverlies the sternothyroid muscle 212 and the thyrohyoid muscle 214. Theother electrode 208b is placed on the cricoid cartilage 216 to the sideof the midline of the pharyngeal region 200. This electrode overlies thesternohyoid muscle 218 and the sternothyroid muscle 212 on one side ofthe midline of the pharyngeal region.

In a third embodiment of the present invention, a pair of electrodes 220is positioned on the skin of the pharyngeal region 200 on the thyrohyoidmembrane 210 on either side of the midline of the pharyngeal region 200.These electrodes overlie the thyrohyoid muscle 214 and the sternohyoidmuscle 218.

In a fourth embodiment of the present invention, a pair of electrodes222 is positioned on the skin of the pharyngeal region 200 on eitherside of the midline of the pharyngeal region 200 proximately midwaybetween the thyroid notch 224 and the cricoid cartilage 216. Theseelectrodes overlie the sternohyoid muscle 218 and the transition zonebetween the sternothyroid muscle 212 and the thyrohyoid muscle 214 oneither side of the midline of the pharyngeal region 200.

In a fifth embodiment of the present invention, a pair of electrodes 226is positioned on the skin of the pharyngeal region 200 on one side ofthe midline of the pharyngeal region 200. One electrode 226a is placedjust lateral to the lesser horn 204 of the hyoid bone 206 proximatelymidway between the hyoid bone 206 and the lower border of the mandible(not shown). This electrode overlies the mylohyoid muscle 228 and thedigastric muscle 230. The other electrode 226b is placed proximate tothe upper end of the thyrohyoid membrane 210 and proximate to the hyoidbone 206 or on the hyoid bone 206 proximately at the level of the lesserhorn 204 of the hyoid bone 206. This electrode overlies thesternothyroid muscle 212 and the thyrohyoid muscle 214.

In a sixth embodiment of the present invention, a pair of electrodes 232is positioned on the skin of the pharyngeal region 200 to the side ofthe midline of the pharyngeal region 200. One electrode 232a is placedon the midline of the pharyngeal region near the chin (not shown). Theother electrode 232b is placed laterally to the other electrode. Theseelectrodes overlie the mylohyoid muscle 228 and the digastric muscle 230in the midline and to one side of the midline of the pharyngeal region200.

EXAMPLE 1

Ninety four patients suffering from dysphagia as a result of a stroke orneurodegeneration were studied. The swallowing ability of each patientwas evaluated to determine the extent and type of dysphagia exhibited bythe patient. The swallowing ability of each patient was assigned anumber which corresponds to a defined swallow state wherein the swallowstates are listed below: swallow state zero is the inability to have apharyngeal contraction; swallow state one is the ability to swallowone's own secretions; swallow state two is the ability to swallow paste,pudding, or similar substances; swallow state three is the ability toswallow honey or similar substances; swallow state four is the abilityto swallow nectar or similar substances; swallow state five is theability to swallow thin liquids; and swallow state six is the ability toswallow water. All of the patients were determined to have swallowingstates of either zero or one, indicating the patient did not have acomplete pharyngeal contraction and had no gag reflex or the ability tohandle secretions. The patients were then subjected to a series oftreatment sessions. The patients were divided into two treatment groups:electrical stimulation and thermal stimulation.

Sixty three patients were subjected to a series of electricalstimulation treatment sessions. Preferably, the patients were subjectedto a least seven electrical stimulation treatment sessions. In eachtreatment session, electrodes were selectively placed on the skin of thepharyngeal region of the patient. The placement of the electrodes wasdetermined by the extent and type of dysphagia exhibited by the patientand, given the extent and type of dysphagia exhibited, those locationswithin the pharyngeal region, when subjected to electrical stimulus,have the possibility of eliciting the strongest and most completeswallow. Electrode placement was adjusted until the patient achieved themost complete swallowing contraction for which he was capable. Once thecorrect electrode placement was determined, the intensity of the currentwas increased by small increments until the tolerance and comfort levellimits are reached in the patient. The optimal intensity was realizedwhen the patient felt a tugging or pinch in the area of stimulation. Thepatient was then subjected to continuous electrical stimulation whereinelectric pulses were continuously generated and delivered to theelectrodes until a complete swallow is achieved or the tolerance levelwas reached in the patient. This step was repeated five to twenty timesin each treatment session wherein the patient was subjected tocontinuous electrical stimulation. If the electrical stimulation wassuccessful in promoting a complete contraction, swabbing of the oralcavity was done and the patient attempted a dry swallow. In thosepatients who did not exhibit any pharyngeal contraction, one or moretreatment sessions were required before an adequate dry swallowoccurred.

Once an adequate dry swallow was achieved, oral intake was provided toassist in the treatment. The consistency of the oral intake isdetermined by the strength of the contraction elicited by the patient.If the patient was able to swallow his own saliva, swabbing the oralcavity with a sponge moistened by water or juice was performed. Thepatient attempted to swallow the water or juice while subjected tocontinuous electrical stimulation. Once the patient had achievedaudible, strong contractions, the patient was challenged with pudding,thick liquid, or ice slush. The patient attempted to swallow thesesubstances while subjected to continuous electrical stimulation. Oncethree to five strong swallows were achieved with the assistance ofelectrical stimulation, the patient attempted to swallow thesesubstances without the assistance of electrical stimulation. Treatmentsessions continued with each patient until the patient's improvementplateaus.

Thirty-one patients were subjected to a series of thermal stimulationtreatment sessions. Preferably, the patients were subjected to a leastseven thermal stimulation treatment sessions. In each treatment session,a mirror or probe was immersed in ice or cold substance. The tonsillarfossa was stimulated with the mirror or probe. The patient then closedhis mouth and attempted a dry swallow. If the stimulation was successfulin promoting a complete contraction, oral intake was provided to assistin the treatment. The consistency of the oral intake is determined bythe strength of the contraction elicited by the patient. Once anadequate dry swallow was achieved, oral intake was provided to assist inthe treatment. The consistency of the oral intake is determined by thestrength of the contraction elicited by the patient. If the patient wasable to swallow his own saliva, swabbing the oral cavity with a spongemoistened by water or juice was performed. The patient attempted toswallow the water or juice while subjected to thermal stimulation. Oncethe patient had achieved audible, strong contractions, the patient waschallenged with pudding, thick liquid, or ice slush. The patientattempted to swallow these substances while subjected to thermalstimulation. Once three to five strong swallows were achieved with theassistance of thermal stimulation, the patient attempted to swallowthese substances without the assistance of thermal stimulation.Treatment sessions continued with each patient until the patient'simprovement plateaus. Once the patient had achieved audible, strongcontractions, the patient was challenged with pudding, thick liquid, orice slush. The patient attempted to swallow these substances whilesubjected to continuous electrical stimulation. Once three to fivestrong swallows were achieved with the assistance of electricalstimulation, the patient attempted to swallow these substances withoutthe assistance of thermal stimulation. Treatment sessions continued witheach patient until the patient's improvement plateaus.

The effectiveness of the electrical stimulation treatments and thethermal stimulation treatments is shown in FIG. 5. FIG. 5 is a graphillustrating the mean swallowing state achieved after electricalstimulation treatment sessions and thermal stimulation treatments. Afterseven treatment sessions, the mean swallowing state of the patientstreated with electrical stimulation was swallow state five or theability to swallow thin liquids. After seven treatment sessions, themean swallowing state of the patients treated with thermal stimulationwas only swallow state one or the ability to handle one's ownsecretions.

The method and device for electrical pharyngeal neuromuscularstimulation of the present invention provides an effective andnon-invasive treatment for dysphagia. The method and device forelectrical pharyngeal neuromuscular stimulation is more effective fortreating dysphagia than traditional treatment methods, such as thermalstimulation. Further, the method and device of the present invention iseffective for treating worst-case dysphagia resulting fromneurodegeneration and strokes.

While various embodiments of a method and device for artificiallypromoting a swallowing reflex have been disclosed, it should beunderstood that modifications and adaptions thereof will occur topersons skilled in the art. Other features and aspects of this inventionwill be appreciated by those skilled in the art upon reading andcomprehending this disclosure. Such features, aspects, and expectedvariations and modifications of the reported results and examples aredearly within the scope of the invention where the invention is limitedsolely by the scope of the following claims.

Having thus described the invention, it is claimed:
 1. An electricalpharyngeal neuromuscular stimulator comprising:a plurality of electrodesadapted to be selectively placed in electrical contact with tissue of apharyngeal region of an associated animal; a generator for generating aseries of electrical pulses in electrical contact with each of theplurality of electrodes, the generator including,a pulse rate modulatorfor generating each of the electrical pulses having a frequencygenerally fixed at 80 hertz, a pulse width modulator for generating eachpulse of the series of electrical pulses at a duration generally fixedat 300 microseconds, and a governor for regulating the electrical pulsessuch that at least one of current so as not to exceed 4.4 milliamps RMSor power so as not to exceed 9.6 MW RMS.
 2. The electrical pharyngealneuromuscular stimulator apparatus for artificially promoting swallowingof claim 1 wherein the generator for generating the series of electricalpulses includes means for increasing incrementally the electricalcurrent value applied to the electrodes.
 3. The electrical pharyngealneuromuscular stimulator apparatus of claim 1 wherein the generatorfurther includes a ramp function to increase the current of the pulseslinearly as a function of time.
 4. The electrical pharyngealneuromuscular stimulator apparatus for artificially promoting swallowingof claim 1 wherein the generator for generating the series of electricalpulses includes means for generating a plurality of discrete cycles eachof which includes a series of electrical pulses.
 5. The electricalpharyngeal neuromuscular stimulator apparatus for artificially promotingswallowing of claim 4 wherein the means for generating the plurality ofdiscrete cycles of the series of electrical pulses includes means forgenerating cycles of pulses up to 30 seconds in length.
 6. Theelectrical pharyngeal neuromuscular stimulator apparatus forartificially promoting swallowing of claim 5 wherein the means forgenerating the plurality of cycles of the series of electrical pulsesincludes means for providing an off period wherein no pulses aregenerated, the off period being between the plurality of cycles of theseries of electrical pulses.
 7. A method for electrical pharyngealneuromuscular stimulation for artificially promoting swallowing, saidmethod comprising the steps of:selectively placing a plurality ofelectrodes in electrical contact with tissue of a pharyngeal region ofan associated animal; and generating a series of electrical pulses inelectrical contact with each of the plurality of electrodes with agenerator, the generator including,a pulse rate modulator for generatingeach of the electrical pulses having a frequency generally fixed at 80hertz, a pulse width modulator for generating each pulse of the seriesof electrical pulses at a duration generally fixed at 300 microseconds,and a governor for regulating the electrical pulses such that at leastone of current so as not to exceed 4.4 milliamps RMS or power so as notto exceed 9.6 MW RMS;wherein the electrical pulses selectively stimulatemuscles located proximate to the selectively placed electrodes toinitiate swallowing.
 8. The method of electrical pharyngealneuromuscular stimulation for artificially promoting swallowing of claim7 wherein the step of generating the series of electrical pulsesincludes increasing incrementally the electrical current value appliedto the electrodes.
 9. The method of electrical pharyngeal neuromuscularstimulation for artificially promoting swallowing of claim 7 wherein thestep of generating the series of electrical pulses includes generating aplurality of cycles of the series of electrical pulses.
 10. The methodof electrical pharyngeal neuromuscular stimulation for artificiallypromoting swallowing of claim 9 wherein the step of generating theplurality of cycles of the series of electrical pulses includesgenerating cycles having pulses up to 30 seconds in duration.
 11. Themethod of electrical pharyngeal neuromuscular stimulation forartificially promoting swallowing of claim 10 wherein the step ofgenerating the plurality of cycles of the series of electrical pulsesincludes providing an off period wherein no pulses are generated, theoff period being situated between the plurality of cycles of the seriesof electrical pulses.
 12. The method of electrical pharyngealneuromuscular stimulation for artificially promoting swallowing of claim11 wherein the step of providing an off period between the plurality ofcycles of the series of electrical pulses includes providing off periodsup to 60 seconds in length.
 13. The method of electrical pharyngealneuromuscular stimulation for artificially promoting swallowing of claim9 wherein the step of generating a series of electrical pulses furtherincludes the step of increasing a magnitude of the pulses in the seriesof electrical pulses as a function of time.
 14. The method of electricalpharyngeal neuromuscular stimulation for artificially promotingswallowing of claim 13 wherein the step of increasing a magnitude of thepluses increases the current value linearly over a selected duration.15. The method of electrical pharyngeal neuromuscular stimulation forartificially promoting swallowing of claim 13 wherein the step ofincreasing a magnitude of the pulses as a function of time comprisesincreasing the electrical current value over a duration of up to 6seconds.
 16. The method of electrical pharyngeal neuromuscularstimulation for artificially promoting swallowing of claim 9 wherein thestep of generating a series of electrical pulses further includes thestep of decreasing a magnitude of the pulses in the series of electricalpulses as a function of time.
 17. The method of electrical pharyngealneuromuscular stimulation for artificially promoting swallowing of claim16 wherein the step of decreasing a magnitude of the pulses includesdecreasing a current value thereof generally linearly.
 18. The method ofelectrical pharyngeal neuromuscular stimulation for artificiallypromoting swallowing of claim 16 wherein the step of decreasing amagnitude of the pulses as a function of time includes the step ofdecreasing the electrical current value over a duration of up to 6seconds.
 19. The method of electrical pharyngeal neuromuscularstimulation for artificially promoting swallowing of claim 7 wherein thestep of selectively placing the plurality of electrodes includesoperatively placing a first electrode at approximately the position of alesser horn of a hyoid bone and operatively placing a second electrodeat approximately the position of a lesser horn of a hyoid bone, thefirst and second electrodes placed substantially symmetrically onopposite sides of a generally longitudinal axis of the pharyngealregion.
 20. The method of electrical pharyngeal neuromuscularstimulation for artificially promoting swallowing of claim 7 wherein thestep of selectively placing the plurality of electrodes includesoperatively placing a first electrode at approximately the position of athyrohyoid membrane overlying a sternothyroid muscle and operativelyplacing a second electrode at approximately a cricoid cartilageoverlying the sternothyroid muscle.
 21. The method of electricalpharyngeal neuromuscular stimulation for artificially promotingswallowing of claim 7 wherein the step of selectively placing theplurality of electrodes includes operatively placing a first electrodeat the position of a thyrohyoid membrane and operatively placing asecond electrode at the position of the thyrohyoid membrane, the firstand second electrodes placed substantially metrically on opposite sidesof a generally longitudinal axis of the pharyngeal region.
 22. Themethod of electrical pharyngeal neuromuscular stimulation forartificially promoting swallowing of claim 7 wherein the step ofselectively placing the plurality of electrodes includes operativelyplacing a first electrode at a position between a thyrohyoid notch and acricoid cartilage and operatively placing a second electrode at aposition between a thyrohyoid notch and a cricoid cartilage, the firstand second electrodes placed substantially symmetrically on oppositesides of a generally longitudinal axis of the pharyngeal region.
 23. Themethod of electrical pharyngeal neuromuscular stimulation forartificially promoting swallowing of claim 7 wherein the step ofselectively placing the plurality of electrodes includes operativelyplacing a first electrode at a position lateral to a lesser horn of ahyoid bone between the hyoid bone and a mandible and operatively placinga second electrode at an end of a thyrohyoid membrane.
 24. The method ofelectrical pharyngeal neuromuscular stimulation for artificiallypromoting swallowing of claim 7 wherein the step of selectively placingthe plurality of electrodes includes operatively placing a firstelectrode at a chin and generally on a longitudinal axis of thepharyngeal region and operatively placing a second electrode in thepharyngeal region generally radially off of the longitudinal axis of thepharyngeal region.
 25. The method of electrical pharyngeal neuromuscularstimulation for artificially promoting swallowing of claim 7 wherein theseries of electrical pulses are provided continuously.